Phase 2
N=12
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Vestibular Schwannoma
Bottom Line
View on ClinicalTrials.gov: NCT04351373 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Surgeon Predicted Use of Fluorescein Sodium in Future Cases — 0; 0; 4; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluorescein Sodium (Drug); YELLOW560 filter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgeon Predicted Use of Fluorescein Sodium in Future Cases |
0; 0; 4; 3; 1 | — |
| PRIMARY Correlation of Fluorescein Sodium With Surgeons' Visual Assessment |
1; 0; 1; 6 | — |
| PRIMARY Correlation of Fluorescein Sodium With Electrostimulation |
1; 0; 3; 4 | — |
| SECONDARY Time to Differential Visualization |
41 | — |
| SECONDARY Average Dose of Sodium Fluorescein Administration |
3.3 | — |
| SECONDARY Total Resection Rate |
6 | — |
Summary
The purpose of this study is to see if there is benefit to using an IV contrast called AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.
Eligibility Criteria
Inclusion Criteria
- Patient with a suspected VS
- Recurrent VS with prior microsurgical resection or radiation therapy
- Clinical indication for microsurgical resection
Exclusion Criteria
- History of allergy to FS
- History of renal failure
- Pregnant women
- Those with inability to give informed consent
- Prisoners and inmates
Data sourced from ClinicalTrials.gov (NCT04351373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.